CONTOUR® NEXT ONE 9765Recalls & reported problems
Ascensia Diabetes Care US Inc. · Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® NEXT ONE Meter; Lancing Device; 10 MICROLET® Colored Lancets (provided sterile); User Guide (including CONTOUR DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card; CONTOUR® NEXT Control Solution. · Class 2
All models of CONTOUR NEXT ONE (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00301939765016), received between Aug 10, 2018 and Jun 18, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Missing Test Results” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Missing Test Results3
Patient problems
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2019Missing Test Results; Missing Test Results
THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF A CONTOUR NEXT ONE METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE METER FOR EVALUATION. A REPLACEMENT METER WAS SENT TO THE CUSTOMER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8706850 ↗MalfunctionFeb 1, 2019Missing Test Results; Missing Test Results
THE CUSTOMER STATED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF A CONTOUR NEXT ONE METER. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER REFUSED TO PROVIDE FURTHER INFORMATION AND THEREFORE, METER IS NOT EXPECTED TO BE RETURNED FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8296135 ↗MalfunctionAug 10, 2018Missing Test Results; Missing Test Results
THE CUSTOMER STATED SOME OF HIS BLOOD GLUCOSE READINGS WERE NOT STORED IN THE MEMORY OF THE CONTOUR NEXT ONE. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE METER FOR EVALUATION. A NEW METER WAS SENT TO HIM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7773931 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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